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2 Disclosure & Disclaimer The views expressed in the presentation are those of the presenters and do not necessarily reflect the views or policies of Accuray Incorporated or its subsidiaries. No official endorsement by Accuray Incorporated or any of its subsidiaries of any vendor, products, or services contained in this presentation is intended or should be inferred. An honorarium is provided by Accuray for this presentation

24 What have we learned since 2006??? Heterogeneous Series cGy By 5 years, median PSA reaches 0.1 ng/ml and by 7 years it reaches < 0.1 ng/ml (Do we really need a 0 PSA??) Question: Is HDR-like 3,800cGy regimen Overkill? Answer (DF): maybe, however, local recurrence is a 10 year endpoint and we are still not there! 3,400cGy salvage regimen gives an ~ identical PSA-response kinetic (small n and more ltd f/u though..) NOTE: EUD =~4300cGy; Same PZ dose escalation design Based on preliminary favorable PSA response/dfs from our lower dose CyberKnife SBRT salvage regimen, as well as multiple other investigators that use lower dose regimens, we commissioned a lower dose arm in 2012 (while also maintaining the high dose arm)

30 What about the few patients that do relapse?? (And this question applies to all local treatments, not just CyberKnife.. Happens after IMRT, proton, Radical Prostatectomy, etc.. ) Traditional Pathways.. Primary local treatment If relapse.. Secondary local treatment if feasible If relapse again.. Androgen Deprivation Therapy (ADT) AKA Hormone treatment

31 What about the few patients that do relapse?? (And this question applies to all local treatments, not just CyberKnife.. Happens after IMRT, proton, Radical Prostatectomy) Traditional Pathways.. Primary local treatment If relapse.. Secondary local treatment if feasible If relapse again.. Androgen Deprivation Therapy (ADT) There is another emerging pathway! Image-guided Hunt and Destroy..

38 Conclusions For those few who DO relapse post-sbrt (intermediate-risk only thus far) They are not failing in the prostate (At least not if SBRT methodology is High Dose HDR-like ) Next generation imaging sometimes finds a solitary focus Sometimes we see a relapse in a?sentinel LN? Response rate of that one in particular is extremely high Well worth looking for before we unleash Lupron on them... Also high response if relapse in a solitary bone If it doesn t work, we STILL have Lupron, etc..

39 Conclusions Is Robotic HDR-like SBRT better than uniform-dosed SBRT? Beauty is in the eye of the beholder! For HDR-like... The most customized match of highest dose to greatest cancer cell burden Allows for extreme dose escalation.. safe and effective More Surgical precision and margins.. More prostatectomy-like Produces a surgical PSA nadir (<0.1 ng/ml) after 7 years Appears precise enough to use as a salvage against local failure of prior RT Just like real HDR brachytherapy...

40 Conclusions SBRT doesn t have to be better than conventional fractionation, it just has to be not worse! It still wins! Cost.. Convenience to the patient.. And.. PSA nadir data suggest.. It just might be better than conventional fractionation

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SYSTEM OVERVIEW Our hands push the technology. Your hands push the results. The CyberKnife System is the first and only robotic radiosurgery system to offer highly precise and customizable, non-surgical

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